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The Survey Report on Topics Such as the Acquisition of Raw Material Cells For the Sake of Industrializing Regenerative Medicine was Compiled

The Ministry of Economy, Trade and Industry (METI) has been concerned that allogeneic human cells (human cells that are not genetically identical because they come from different patients), which are used as raw material for the manufacture of regenerative medical products, cannot be sourced in adequate supply in Japan despite possessing properties and merits with respect to quality control and cost that autologous cells (a patient’s own cells) do not. METI has compiled a report on the issues of obtaining allogeneic human cells in Japan and measures to be taken in order to support the development and commercialization of allogeneic cell-based products.

1. Survey Background

Allogeneic cell-based products have merits that autologous cell-based products do not; for example, their use in mass production of product has advantages with respect to quality control and cost. However, Japan lags behind many other industrialized economies in the development of allogeneic cell-based products. Therefore, the stable acquisition of allogeneic cells that are harvested in Japan is an important issue in order to promote product development and commercialization.

For that reason, a research group of experts (Chairperson: Ida Ryuichi, Distinguished Visiting Professor at the Doshisha University, Graduate School of Global Studies) was established, and its group members tasked with clarifying issues surrounding the sourcing of allogeneic human cells and discussing measures to resolve those issues. During the discussions, they focused on the utilization of human cells and tissues that can be extracted through typical operational procedures so that additional invasive procedures are not necessary.

2. Revealed issues

In regards to obtaining allogeneic human cells for raw material of regenerative medical products in Japan, the group members identified practical issues surrounding the acquisition and provision of the cells, including quality assurance, the acquisition of consent from cell donors, personal information protection, and cooperation between medical institutions and other enterprises, as well as the need for improving societal understanding in order to better facilitate the sourcing and increase the supply of cells. In addition, the group members identified the importance of a mediation agency that would serve as a liaison between entities, for example, between a medical institution where human cells and tissues are extracted and a regenerative medicine enterprise. Such a liaison agency would deal primarily with practical issues.

3. Future challenges

The group members concluded that for the time being, they would focus on practical studies for actual obtainment and provision of organ tissue excised through surgery, which are less likely to be accompanied by problems when being used, along with technical studies to increase quality. In addition, they reached an agreement that, in the future, they would need to examine issues regarding the provision of cells and tissues from living-donor volunteers and as well as the acquisition of human cells and tissues that are utilized for drug discovery research.

Release date

May 19, 2015

Division in Charge

Bio-Industry Division, Manufacturing Industries Bureau

Ministry of Economy, Trade and Industry
1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901, Japan Tel: +81-(0)3-3501-1511
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